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Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase 3, Randomized, Open-label, Multi-center FESTnd Study.

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作者：
Li Zhang[1] ; Li Meng[2] ; Bingcheng Liu[1] ; Yanli Zhang[3] ; Huanling Zhu[4] ; Jiuwei Cui[5] ; Aining Sun[6] ; Yu Hu[7] ; Jie Jin[8] ; Hao Jiang[9] ; Xi Zhang[10] ; Yan Li[11] ; Li Liu[12] ; Wanggang Zhang[13] ; Xiaoli Liu[14] ; Jian Gu[15] ; Jianhui Qiao[16] ; Guifang Ouyang[17] ; Xin Liu[18] ; Jianmin Luo[19] ; Ming Jiang[20] ; Xiaobao Xie[21] ; Jianyong Li[22] ; Chunting Zhao[23] ; Mei Zhang[24] ; Tonghua Yang[25] ; Jianxiang Wang[1,*1] ;
机构： [1]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin. [2]Tongji Hospital Tongji Medical College of Huazhong University of Science &Technology, Wuhan. [3]Henan Cancer Hospital, Zhengzhou. [4]The West China College of Medicine, Sichuan University, Chengdu. [5]The First Hospital of Jilin University, Changchun. [6]The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou. [7]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan. [8]The First Affiliated Hospital Zhejiang University, Hangzhou. [9]Peking University People’s Hospital, Peking University Institute of Hematology, Beijing. [10]The Second Affiliated Hospital of Army Medical University, Chongqing. [11]The First Hospital of China Medical University, Shenyang. [12]Tangdu Hospital, Fourth Military Medical University. [13]The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an. [14]Nanfang Hospital, Southern Medical University, Guangzhou. [15]Clinical Medical College of Yangzhou University/Yangzhou Institute of Hematology, Yangzhou. [16]The 307th Hospital of Military Chinese People's Liberation Army, Beijing. [17]Ningbo First Hospital, Ningbo. [18]AnHui Provincial Hospital, Hefei. [19]Hebei Medical University Second Hospital, Shijiazhuang. [20]The First Affiliated Hospital of Xinjiang Medical University, Urumqi. [21]The First People's Hospital of Changzhou, Changzhou. [22]The First Affiliated Hospital of Nanjing Medical University, Nanjing. [23]The Affiliated Hospital of Qingdao University, Qingdao. [24]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an. [25]The First People's Hospital of Yunnan Province, Kunming.
出处：
DOI： 10.1158/1078-0432.CCR-20-1600
ISSN：

关键词： flumatinib tyrosine kinase inhibitor chronic myeloid leukemia chronic phase BCR-ABL1

摘要：
Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. We evaluated the efficacy and safety of flumatinib versus imatinib, for first-line treatment of chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML-CP). In this study, 394 patients were randomized 1:1 to flumatinib 600 mg once daily (n=196) or imatinib 400 mg once daily (n=198). The rate of major molecular response (MMR) at 6 months (primary end point) was significantly higher with flumatinib than with imatinib (33.7% vs 18.3%, P=0.0006), as was the rate of MMR at 12 months (52.6% vs 39.6%, P=0.0102). At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs 53.3%, P<0.0001). Compared with patients receiving imatinib, more patients receiving flumatinib achieved MR4 at 6, 9 and 12 months (8.7% vs 3.6%, P=0.0358; 16.8% vs 5.1%, P=0.0002; 23.0% vs 11.7%, P=0.0034, respectively). No patients had progression to accelerated phase or blast crisis in the flumatinib arm versus 4 patients in the imatinib arm by 12 months. Adverse events of edema, pain in extremities, rash, neutropenia, anemia, and hypophosphatemia were more frequent in imatinib arm, whereas diarrhea and alanine transaminase elevation were more frequent in flumatinib arm. Patients receiving flumatinib achieved significantly higher rates of responses, faster and deeper responses compared with those receiving imatinib, indicating that flumatinib can be an effective first-line treatment for CML-CP. This trial was registered at www.clinicaltrials.gov as NCT02204644. Copyright ©2020, American Association for Cancer Research.

基金：
The present study was supported by Hansoh Pharmaceuticals.
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外文
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出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2021]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin.
共同第一作者：
通讯作者：
通讯机构： [1]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin. [*1]State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 288 Nanjing Road, Tianjin, 300020, China.
推荐引用方式(GB/T 7714)：
Li Zhang,Li Meng,Bingcheng Liu,et al.Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase 3, Randomized, Open-label, Multi-center FESTnd Study.[J].CLINICAL CANCER RESEARCH.2021,27(1):70-77.doi:10.1158/1078-0432.CCR-20-1600.
APA：
Li Zhang,Li Meng,Bingcheng Liu,Yanli Zhang,Huanling Zhu...&Jianxiang Wang.(2021).Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase 3, Randomized, Open-label, Multi-center FESTnd Study..CLINICAL CANCER RESEARCH,27,(1)
MLA：
Li Zhang,et al."Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase 3, Randomized, Open-label, Multi-center FESTnd Study.".CLINICAL CANCER RESEARCH 27..1(2021):70-77

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